A Prescription Audit of Inpatient Department of Super Speciality Hospital in National Capital Region of India

June 7, 2023 updated by: Satyam Suman, Kakatiya University

A Prescription Audit of Inpatient Department of National Accreditation Board for Hospitals and Healthcare Providers Approved Super Speciality Hospital in National Capital Region of India

Prescription auditing is the art to check the detailing, compatibility and performance of the generated prescription from the physician to the pharmacist and patient, by means of the WHO checklist for prescription auditing. An audit is defined as the review and evaluation of the healthcare procedures and documentation to compare the quality of care provided, with accepted standards.

In this study, we will collect In-patient prescriptions from Fortis Hospital. And it will be evaluated for 13 list out parameters i.e Hospital unique ID, patient name, age, sex, weight, date of consultation, cleanliness and legibility, brief history, allergies, clinical examination, presumptive or definite diagnosis, medicine prescribed by generic name, dose, duration, history of a previous adverse event, appropriate abbreviations used, drug-drug interaction, drug duplication, doctor name, registration number and signature. The study is analyzed by Statistical Process Control (SPC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Aim of the study:

The aim of the study is to evaluate the quality of the prescription provided to the inpatient.

Objectives of the study:

To study the quality of good prescription In minimization of prescription errors and medication errors Also to comply with good clinical practice Enhancement of patient safety In the maintenance of rational prescribing To study the quality of care provided by the hospital to the patient

Plan of study:

To select the patient based on inclusion and exclusion criteria To collect the information from IP prescription and drug chart To identify prescribing errors and medication error To study the management of good prescription

Methodology:

Study Sites: Fortis Hospital, Noida, Uttar Pradesh (INDIA) Study Design: Observational cohort study Study Duration: 2 months (March, 2023 and May, 2023)

Study Sites: Fortis Hospital, Noida, Uttar Pradesh (INDIA) Study Design: Observational cohort study Study Duration: 2 months (March, 2023 and May, 2023)

Subject Eligibility:

  1. Inclusion Criteria Participants who are willing to participate Participants who are admitted in the in-patient department Participants admitted during the study period Participants who have a prescription which is legible and complete
  2. Exclusion Criteria Participants who are unwilling to provide the required information Participants who are not admitted the in-patient department Participants whose prescription is not legible and competent
  3. Source of the data: Review of In-patient prescription

Sample Size:

300 prescriptions

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Uttar Pradesh
      • Noida, Uttar Pradesh, India, 201301
        • Fortis Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Select the patient based on inclusion and exclusion criteria Collect the information from IP prescription and drug chart Identify prescribing errors and medication error To study the management of good prescription

Description

Inclusion Criteria:

  • Participants who are willing to participate
  • Participants who are admitted in the in-patient department
  • Participants admitted during the study period
  • Participants who have a prescription which is legible and complete

Exclusion Criteria:

  • Participants who are unwilling to provide the required information
  • Participants who are not admitted the in-patient department
  • Participants whose prescription is not legible and competent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Compliance
Prescription properly filled for specific parameters
Other: Prescription data collection
Prescription data collection
Non Compliance
Prescription is not filled with specific parameters
Other: Prescription data collection
Prescription data collection
Not available - NA
Prescription does not contain specific data
Other: Prescription data collection
Prescription data collection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage prescription
Time Frame: March 2023 and May 2023
Prescription filled for specific parameter
March 2023 and May 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kakatiya University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fortis Hospital, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FORTIS/IEC/2023/MAR/PA02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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